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Dexcom G7 Overpatch 10 Pack MT-1000392

by Dexcom

Dexcom G7 Overpatch 10 Pack MT-1000392 is a Class I device made by Dexcom, cleared under FDA 510(k) K213919 on 7 Dec 2022 and listed in FDA GUDID since 16 Feb 2024 (UDI-DI 00386270004024), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

Recall on shared 510(k) K213919; other models may be affected

Documents

510(k) K213919

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00386270004024 UDI-DI Date16 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213919 Date7 Dec 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213919 decided 7 Dec 2022 Active
  • FDA GUDID UDI-DI 00386270004024 listed 16 Feb 2024 Listed

Recalls

4 recalls · 4 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2446-2025 FDA Class I initiated 24 Jul 2025 on shared 510(k) K213919
    • Ongoing Z-2448-2025 FDA Class I initiated 24 Jul 2025 on shared 510(k) K213919
    • Ongoing Z-2447-2025 FDA Class I initiated 24 Jul 2025 on shared 510(k) K213919

    The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.

    • Ongoing Z-1944-2025 FDA Class I initiated 12 May 2025 on shared 510(k) K213919

    Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

6 dated events

  1. Cleared FDA 510(k) K213919
  2. Listed FDA GUDID 00386270004024
  3. Recall initiated FDA recalls Z-1944-2025
  4. Recall initiated FDA recalls Z-2446-2025
  5. Recall initiated FDA recalls Z-2448-2025
  6. Recall initiated FDA recalls Z-2447-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dexcom G7 Overpatch 10 Pack
Generic name
Percutaneous interstitial fluid glucose monitoring system, electrochemical
Model / reference
MT-1000392
Primary DI / UDI-DI
00386270004024
510(k) Number
FDA product code
KGX
GMDN term
Percutaneous interstitial fluid glucose monitoring system, electrochemical
Device class
Class I
Regulation number
880.5240
GUDID distribution status
In Commercial Distribution

Related devices

Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical

Cleared under the same submission (K213919)

and 8 more cleared under K213919

Other devices from Dexcom

See all devices from Dexcom →

Properties

  • Supplied sterile
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (11, all answered No)